View Information Collection Request (ICR) Package
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View Generic ICR - Agency Submission
COMMENT
Time Remaining
Days
HR
Min
Sec
OMB Control No:
0910-0891
ICR Reference No:
202608-0910-012
Status:
Received in OIRA
Previous ICR Reference No:
202302-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
HFP
Title:
Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
09/24/2026
Requested
Previously Approved
Expiration Date
36 Months From Approved
10/31/2026
Responses
10,664
20,464
Time Burden (Hours)
3,870
7,394
Cost Burden (Dollars)
0
0
Abstract:
This is a request is for approval of a Generic Information Collection that utilizes qualitative methods (i.e., individual in-depth interviews (IDIs), focus groups, small group discussions, and observations) for studies about food and cosmetic products, dietary supplements, and animal food and feed. This information will be used to inform the regulatory science knowledge base, as well as to explore areas of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency. This information may also be used to help develop communications and educational messages related to public health.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
91 FR 20693
04/17/2026
30-day Notice:
Federal Register Citation:
Citation Date:
91 FR 57895
09/11/2026
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
0
ICR Summary of Burden
Total Request
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
10,664
20,464
0
-9,800
0
0
Annual Time Burden (Hours)
3,870
7,394
0
-3,524
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
Based on a review of the information collection since our last request for OMB approval, we have adjusted our burden estimate based on actual usage of this collection of information and have decreased the number of responses and hours. We have reduced our estimate for the number of responses from 19,600 to 9,800 responses (a decrease of 9,800 responses) and reduced the number of hours from 7,048 to 3,524 hours (a decrease of 3,524 hours) based on our experience conducting these collections of information over the past three years.
Annual Cost to Federal Government:
$1,060,917
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Christopher Colburn 301-415-6157 cxc7@nrc.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
09/24/2026
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